Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section

September 23, 2024 updated by: Betul Kozanhan, Konya Meram State Hospital
The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42005
        • Betul Kozanhan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elective cesarean operation
  • Able to give informed consent

Exclusion Criteria:

  • Patients with neurological or psychological diseases
  • patients with chronic analgesic and antidepressant drug use
  • Patients unable to communicate
  • Patients previously treated with TEAS or acupuncture,
  • Patients with heart failure and have pace-maker,
  • patient with local infection in the TEAS area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group teas
Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device.
Device: Transcutaneous Electrical Acupoint Stimulation
Transcutaneous Electrical Acupoint Stimulation
Sham Comparator: Control Group
In the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied.
Device: Transcutaneous Electrical Acupoint Stimulation
Transcutaneous Electrical Acupoint Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery
Time Frame: The first 24 hours postoperatively
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2021

Primary Completion (Actual)

January 24, 2022

Study Completion (Actual)

January 24, 2022

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TEAS and ObsQoR-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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